QSYMIA Drug Patent Profile

When do Qsymia patents expire, and what generic alternatives are available?

Qsymia is a drug marketed by Vivus and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in seventeen countries.

The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

DrugPatentWatch^® Generic Entry Outlook for Qsymia

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 24, 2025. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for QSYMIA

International Patents:	40
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	17
Patent Applications:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for QSYMIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QSYMIA
What excipients (inactive ingredients) are in QSYMIA?	QSYMIA excipients list
DailyMed Link:	QSYMIA at DailyMed

See drug prices for QSYMIA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for QSYMIA

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

NDA:

022580

Dosage:

CAPSULE, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for QSYMIA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Novo Nordisk A/S	Phase 4
VIVUS LLC	Phase 4
Alvogen Korea	Phase 4

See all QSYMIA clinical trials

Pharmacology for QSYMIA

Drug Class	Sympathomimetic Amine Anorectic
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers
Physiological Effect	Appetite Suppression Decreased Central Nervous System Disorganized Electrical Activity Increased Sympathetic Activity

Anatomical Therapeutic Chemical (ATC) Classes for QSYMIA

A08AA	Centrally acting antiobesity products
A08A	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A08	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A	Alimentary tract and metabolism

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for QSYMIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QSYMIA	Extended-release Capsules	phentermine hydrochloride; topiramate	3.75 mg/23 mg 7.5 mg/46 mg 11.25 mg/69 mg 15 mg/92 mg	022580	1	2013-07-18

US Patents and Regulatory Information for QSYMIA

QSYMIA is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PATIENT POPULATION.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting QSYMIA

FDA Regulatory Exclusivity protecting QSYMIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012		RX	Yes	Yes
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012		RX	Yes	No
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012		RX	Yes	No			Y
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012		RX	Yes	Yes
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012		RX	Yes	No
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012		RX	Yes	No			Y

Expired US Patents for QSYMIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012

International Patents for QSYMIA

When does loss-of-exclusivity occur for QSYMIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Cyprus

Denmark

European Patent Office

Hong Kong

Israel

Japan

Mexico

Portugal

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QSYMIA around the world.

Country	Patent Number	Title	Estimated Expiration
Chile	2010001365	Uso de fentermina en combinacion con topiramato para tratar la obesidad mediante una reduccion de peso en una persona.
Brazil	PI0914985	composição de baixa dose de topiramato/fentermina e métodos de utilização dessa
World Intellectual Property Organization (WIPO)	2009152189
Spain	2606041
Mexico	2010013505	REGIMEN DE DOSIFICACION ESCALANTE PARA EFECTUAR LA PERDIDA DE PESO Y EL TRATAMIENTO DE OBESIDAD. (ESCALATING DOSING REGIMEN FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY.)
Czech Republic	9804278

Supplementary Protection Certificates for QSYMIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2317997	CA 2021 00049	Denmark		PRODUCT NAME: PHENTERMIN OG TOPIRAMAT; NAT. REG. NO/DATE: 63166, 63167, 63168, 63169 20210705; FIRST REG. NO/DATE: IS IS/1/21/018/01-04 20210212